RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

Overall survival [ Time Frame: From the date of randomization to the date of death due to any cause. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of unexpected grade ≥ 3 adverse events and/or clinically significant decrement in patient-reported quality of life (PR-QOL) among patients treated with TAK-700 [ Time Frame: From the date of randomization to the date of first documented AE ≥ grade 3 and/or to the date of first clinically significant decrement in patient-reported quality of life (PR-QOL) among patients treated with TAK-700. ] [ Designated as safety issue: Yes ]

Rates and cumulative incidence of biochemical control - freedom from PSA failure [ Time Frame: From the date of randomization to the date of first documented biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA) or the initiation of salvage androgen deprivation therapy. ] [ Designated as safety issue: No ]

General clinical treatment failure-free interval [ Time Frame: From the date of randomization to the date of first documented general clinical treatment failure defined as: PSA > 25 ng/ml or documented local disease progression or regional or distant metastasis or initiation of androgen deprivation therapy. ] [ Designated as safety issue: No ]

Prostate cancer-specific survival and other-cause survival [ Time Frame: From the date of randomization to the date of death due to prostate cancer for prostate cancer-specific survival and to the date of death due to other causes for other-cause survival. ] [ Designated as safety issue: No ]

Change in fatigue from baseline to 1 year, as measured by PROMIS [ Time Frame: One year from the date of randomization. ] [ Designated as safety issue: No ]

Changes in PR-QOL as measured by EPIC [ Time Frame: From the date of randomization to the week prior to RT start, to the last week of RT and 1 year and 2.5 years after the initiation of therapy. ] [ Designated as safety issue: No ]

Assessment of quality-adjusted survival using the EQ-5D [ Time Frame: From the date of randomization to the week prior to RT start, to the last week of RT and 1 year and 2.5 years after the initiation of therapy. ] [ Designated as safety issue: No ]

Nadir and average serum testosterone at 12 and 24 months during treatment [ Time Frame: From baseline to 12 months and 24 months of treatment. ] [ Designated as safety issue: No ]

Lipid profiles at 12 and 24 months [ Time Frame: From baseline to 12 months and 24 months. ] [ Designated as safety issue: No ]

Changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up [ Time Frame: From baseline to 2 years from the start of treatment and after that every year for 3 more years. ] [ Designated as safety issue: No ]

Incidence of adverse events ascertained via Common Toxicity Criteria for Adverse Effects (CTCAE) version 4 [ Time Frame: From the start of therapy to 6 months of follow-up. ] [ Designated as safety issue: Yes ]

Rate of recovery of testosterone to > 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up [ Time Frame: From the treatment end date to the date when testosterone levels first recovered to > 230 ng/dl within 12 months and 24 months of treatment. ] [ Designated as safety issue: No ]

Median time to recovery of testosterone to > 230 ng/dL during the first five years of follow-up [ Time Frame: From the date of ranomization to the post-treatment end date when testosterone levels first recovered to > 230 ng/dl within 5 years after treatment. ] [ Designated as safety issue: No ]

Cumulative incidence of relevant clinical survivorship endpoints including new diagnosis of type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, or osteoporotic fracture [ Time Frame: From the date of randomization to the date of first reported new incidence of any of the above mentioned clinical endpoints. ] [ Designated as safety issue: No ]

Rates and cumulative incidence of local/regional progression [ Time Frame: From the date of randomization to the date of the documented presence of local/regional recurrence. ] [ Designated as safety issue: No ]

Rates and cumulative incidence of distant metastases [ Time Frame: From the date of randomization to the date of documented distant recurrence. ] [ Designated as safety issue: No ]

Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations (risk group):

Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage

GS ≥ 8, PSA < 20 ng/mL, T stage ≥ T2

GS ≥ 8, PSA ≥ 20-150 ng/mL, any T stage

GS ≥ 7, PSA ≥ 20-150 ng/mL, any T stage

Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) agonist or antiandrogen therapy, within 180 days of randomization

Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethyl- stilbestrol [DES]), or surgical castration (orchiectomy), may have been started prior to registration, provided that registration is within 50 days of beginning ADT; please note: if the patient has started ADT he will not be eligible to participate in the quality of life component of this study

Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 2.0 cm

No distant metastases (M0) on bone scan within 90 days prior to registration

Equivocal bone scan findings are allowed if plain films are negative for metastasis

No definite evidence of metastatic disease

Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score ≤ 15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP)

Prior TURP is permitted for patients who receive external-beam radiotherapy (EBRT) only

PATIENT CHARACTERISTICS:

Height, weight, Zubrod performance status 0-1

Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3

Platelets ≥ 100,000 cells/mm^3

Hemoglobin ≥ 8.0 g/dL (The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)

Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy) may have been started prior to registration, provided that registration is within 50 days of beginning ADT.

Patients, even if surgically sterilized (i.e., status post vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and for 4 months (120 days) after the last dose of study drug

No prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years

No uncontrolled hypertension despite appropriate medical therapy within 21 days prior to registration (blood pressure of greater than 150 mm Hg systolic and 90 mm Hg diastolic at 2 separate measurements no more than 60 minutes apart during screening visit)

No serious infection within 14 days prior to registration

No uncontrolled nausea, vomiting, or diarrhea (CTCAE grade ≥ 3) despite appropriate medical therapy at the time of registration

No known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Prior testosterone administration is allowed if last administered at least 90 days prior to registration

No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason

No prior systemic chemotherapy for prostate cancer

Prior chemotherapy for a different cancer is allowed

No prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields

No previous hormonal therapy for > 50 days

No chronic treatment with glucocorticoids within one year

No major surgery within 14 days prior to registration

No other investigational agent

No other anticancer therapy

No concurrent hormonal therapies including estrogens or herbal products

No concurrent ketoconazole or aminoglutethimide

No chronic use of systemic corticosteroids, such as oral prednisone

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01546987